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type1.science
Phase 2TerminatedNCT00965458

T1DAL: Alefacept in new-onset type 1 diabetes

Phase-2 trial targeting CD2-high memory T cells with alefacept. The 12-month primary 2-hour C-peptide endpoint was not significant, but 4-hour C-peptide, insulin use, hypoglycemia and 24-month outcomes favored treatment.

Primary endpoints

  • Change from baseline in 2-hour mixed-meal stimulated C-peptide AUC at 12 months

Results so far

The primary 12-month 2-hour C-peptide endpoint was not significant (P=0.065), but key secondary measures favored alefacept. At 24 months, both 2-hour and 4-hour C-peptide AUCs were significantly greater, insulin use was lower, and major hypoglycemia was about 50% lower.

The full picture

T1DAL is not a route to an available product, because alefacept is withdrawn, but it is a key mechanistic trial for memory T-cell targeting in T1D.